Developing Language to Communicate Privacy and Confidentiality Protections to Potential Clinical Trial Subjects: Meshing Requirements under Six Applicable Regulations, Laws, Guidelines and Funding Policies

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food andDrugAdministration regulations, Health...

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Bibliographic Details
Published inThe journal of research administration Vol. 50; no. 2SE; pp. 20 - 44
Main Authors Ennever, Fanny K, Nabi, Sean, Bass, Patricia A, Huang, Lilly O, Fogler, Emily C
Format Journal Article
LanguageEnglish
Published Society of Research Administrators, Inc 22.06.2019
Subjects
Access control
Clinical trials
Company systems management
Confidential communications
Ethical aspects
Government regulation
Information management
Laws, regulations and rules
Management
Medical research volunteers
Methods
Records management
Safety and security measures
United States
Online AccessGet full text
ISSN1539-1590

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Summary:Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food andDrugAdministration regulations, Health Insurance Portability and Accountability Act regulations, International Council for Harmonisation guidelines, the Confidentiality of Substance Use Disorder Patient Records statute, and Certificates of Confidentiality provisions under the 21st Century Cures Act, A consent form template is presented as one example of language that incorporates all of these requirements in an integrated manner that addresses some of the tensions among the various requirements.
ISSN:1539-1590